Many diseases well known to the physician or clinician are "blood borne" diseases, i.e., they are characterized by the presence of the disease causing agent in blood. The agent is carried by the blood to various organs and cells, thereby spreading the infection. Among the diseases and pathological conditions which are characterized by this factor include the parasite diseases such as malaria, bacterial diseases such as tuberculosis, and viral diseases including herpes and AIDs. Additionally, when cancers metastasize, the "seed" cancers are frequently carried by blood to other organs.
Logically, treatment of these blood borne diseases would involve administration of an agent which inactivates them. In the case of treating the infection or disease via treatment of blood, however, this must be done in a manner which preserves the integrity of the blood itself. This is extremely difficult to do in practice because infectious agents such as bacteria, parasites, viruses and so forth usually possess adaptive structures which make them somewhat resistant to antibody attack or other immune system responses. These adaptations render the infectious agents more resilient to therapeutic agents than the blood cells and blood components themselves. As a result treatment protocols must then contend with the problem of harming the blood itself. While this is appropriate in some cases, in most cases it is not. In many diseases, including AIDs, the patient or subject has become so debilitated by the infection that additional trauma is to be avoided at all costs.
Ozone ("O.sub.3 ") is well known as an inhibitor of pathogenic organisms. In vitro experiments have shown that pure ozone inactivates coliform, S. aureus, and Aeromonas hydrophilia, (Lohr, et al., J. Aquaric Aquat Sci 4: 1-8 (1984); enteroviruses (Ivanova, et al., Vopr. Virusol 6:693-698 (1983); poliovirus 2 and coxsachie (Roy, et al., Appl. Envir Microbiol 41:718-723 (1981); as well as other microorganisms. While a full understanding of why or how pure O.sub.3 inactivates these microorganisms is lacking, one theory hypothesizes that peroxidation of membrane components, such as phospholipids and lipoproteins is involved. See, e.g., Mudd, et al. Atmos. Environ 3: 669-682 (1969); Ishizaki, et al., Water Res 21(7): 823-828 (1987). Of course, normal cells also possess lipoproteins and phospholipids in their cell membranes, and disruption of these would also be expected. In experiments on mammals, pure O.sub.3 has been shown to exhibit a variety of effects, both positive and negative. Mice are extremely sensitive, showing an LD.sub.50 of 22 ppm over a course of 3 hours of inhalation therapy. See Mittler, et al, AMA Arch. Ind. Health 15: 191-197 (1957). Overdoses are marked by pulmonary edema and hemorrhaging, evidencing weakness of cellular structures. Exposure to ambient ozone concentration (0.24 ppm) for two hours caused human subjects to show drops in respiratory capacity, inhibition of certain cell functions, and wide fluctuations in enzyme activities. Note in this regard Folinsbee, et al., Rev. Environ. Health 3:211-240 (1987); Hackney, et al., J. Appl. Physiol. Respirat. Environ. Exercise Physiol 43: 82-85 (1977); Melton, Aviation, Space and Environmental Med. 53: 105-111 (1982); Menzel, Toxicol & Environ. Health 13: 183-204 (1984).
In summary, while O.sub.3 is unquestionably known as a potential antimicrobial, antiviral, etc., use in its pure form is indicated only in vitro. Its effects upon subjects including mice and humans indicates the potential for great harm. One notes, for example, U.S. Pat. No. 4,632,980 to Zee, et al., which discourages the bubbling of O.sub.3 through blood, due to the potential for hemolysis. This patent teaches the decontamination of blood using O.sub.3 either alone, with air, or with inert gases, via contact from 0.5 to 4 hours. The patent teaches purifying blood for later use in transfusion, e.g., but does not show that the treated blood has any therapeutic effect on the subject in which it is injected. No therapeutic efficacy for pure O.sub.3 is described.
There has been some research where mixtures of oxygen and ozone have been administered to subjects via intravascular injection. See, in this regard Rokitanshy, Hospitalis 52:643, 711 (1982); Viebahn, OzoNachrichten 4: 18-30 (1985); Washuttl, et al., Erfahr 28: 766 (1979). At the outset, one notes that intravascular injection of any gas or gas mixture must be done with extreme care. The risk of a gas bubble reaching the heart is well known to cause serious injuries and death. The above studies showed that the injections, not surprisingly, resulted in enhanced activation of enzymes involved in peroxide and oxygen radical scavenging, with expected biochemical processes shifting their equilibria to account for the increased concentrations. No studies were done to determine what effect the injections had on infectious agents in the blood. Given the effect pure ozone has on living organisms, as described, and the lack of any information on the efficacy of mixtures of ozone and oxygen on infections, it was not to be expected that such a mixture would be useful as an in vivo agent for the treatment of blood borne infection.
It has now been found, surprisingly, that a mixture of oxygen and ozone may be administered in vivo to patients or subjects having a blood borne infection, resulting in selective inactivation of the infectious agent with no resulting harm to the subject's blood. The therapeutic treatment is efficacious against the difficult agents, including viruses such as herpes and HIV. Further, via appropriate choice of parameters it is possible to in fact bubble the gas mixture through blood, without the hemolysis expected.
Hence it is an object of the invention to provide a method for inactivating infectious agents in blood via administering a non-toxic, infectious agent inactivating amount of a mixture of oxygen and ozone to a patient.
It is a further object of the invention to provide a treatment efficacious against viral infections using the above mentioned O.sub.3 /O.sub.2 mixture.
It is yet a further object of the invention to provide autohemotherapy and rectal insufflation based therapies using O.sub.3 /O.sub.2 mixtures as above.
It is still a further object of the invention to provide a method for inactivating blood born viruses such as herpes and HIV via use of the aforementioned mixture.
How these and other objects of the invention are achieved will be seen from the disclosure which follows.